Emotion, Mood and Executive Function in Parkinson`s Disease (PD) (RasQ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by St. Josef Hospital Bochum.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
St. Josef Hospital Bochum
ClinicalTrials.gov Identifier:
NCT01385735
First received: June 28, 2011
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

The current study aims to assess the effect of an 8 week Azilect treatment (as adjunct therapy to levodopa) on affect perception and emotional expressiveness in a double-blind placebo-controlled study.


Condition Intervention Phase
Parkinson Disease
Drug: Rasagiline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson`s Disease

Resource links provided by NLM:


Further study details as provided by St. Josef Hospital Bochum:

Primary Outcome Measures:
  • Assess the effect of Azilect on mood, recognition of facial and vocal affect and emotional expressiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • Discrimination Faces
    • Discrimination Affect
    • Affect Naming -Faces
    • Discrimination linguistic prosody
    • Discrimination affective prosody
    • Affect naming -congruent and incongruent affective prosody Visual Analogue Scales of emotional expressiveness
    • Rating by study physician and relative
    • Self-rating by patient Assessment of executive function
    • Working Memory (n-back task, digit backward)
    • Verbal Fluency (Regensburger Wortflüssigkeitstest) Beck Depression Inventary (BDI) Apathie Evaluations-Skala (AES) Social Activity Scale - self assessment PDQ-39- self-assessment


Secondary Outcome Measures:
  • Effect on motor function in PD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease Rating Scale


Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo 1 Tbl per day, 12 week (84 days) duration
Drug: Placebo
Placebo 1 Tbl per day, 12 week (84 days) duration
Active Comparator: Rasagiline
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Drug: Rasagiline
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Other Name: Azilect EU/1/04/304/001-007

Detailed Description:

Parkinson`s disease (PD) is associated with a range of cognitive impairments, most notably deficits of higher order cognitive control mechanisms referred to as "executive dysfunction". These problems have consistently been related to dysfunction of fronto-striatal circuitry (summary see Stocchi & Brusa, 2000). Executive function impairments may already be present in early stages of PD (Uekermann et al., 2004) and their severity may be exacerbated by affective changes such as depression (Uekermann et al., 2003). In addition to cognitive problems, PD patients frequently suffer from mood changes, in particular apathy (Kirsch-Darrow et al., 2006) and from affect processing impairments, relating to both the ability to decode the affective state of other people on the basis of facial expressions or prosody and to the ability to adequately express the patients` own emotions (e.g. Breitenstein et al., 1998; Zgaljardic et al., 2003, Pell & Leonard, 2005). The capacity for emotion perception was found to be linked to the severity of executive dysfunction; affective and cognitive changes are thus not independent, at least in patients with moderate PD (Breitenstein et al., 2001).

In a recent drug monitoring study by Lundbeck GmbH/TEVA Pharma GmbH based on a small group of PD patients (n=29), introduction of Azilect (Rasagiline) therapy was associated with a significant improvement of PD patients` emotional expressiveness (e.g. facial expression, gestures, voice intonation) over an 8 week observation period. Significant improvements were observed for self-ratings of emotional expressiveness as well as ratings by physicians and relatives. The lack of a placebo-control group, however, does not allow any firm conclusions with regard to the specificity of these effects.

Intact affect recognition and an adequate ability to express emotions are of critical importance for social interaction. The therapeutic efficacy of drug treatment on non-motor symptoms in PD has so far only rarely been addressed. The documentation of a beneficial effect of Azilect on emotional processing would be of great relevance for the quality of life of PD patients and greatly enhance their ability to participate in social life.

The addition of a placebo control group is critical for the assessment of the specificity of the expected beneficial effects of Azilect.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • idiopathic PD
  • age range 30-75 yrs, HY I-III
  • stable medication for at least 4 weeks prior to baseline
  • Native speakers (German)
  • signing of informed consent form

Exclusion Criteria:

  • clinically significant depression (BDI>13)
  • freezing, pronounced fluctuations
  • other neurological or psychiatric disorders
  • dementia (MMSE<25)
  • treatment with the MAO-B-inhibitor Selegiline, antidepressants
  • any contraindication according to SmPC
  • participation in another interventional study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385735

Contacts
Contact: Dirk Woitalla, MD 0049234509 ext 2403 dirk.woitalla@rub.de
Contact: Anke Hartung 0049234509 ext 2403 a.hartung@klinikum-bochum.de

Locations
Germany
St. Josef Hospital Not yet recruiting
Bochum, Nordrhein-Westfalen, Germany, 44791
Principal Investigator: Dirk Woitalla, MD         
Sub-Investigator: Irene Daum, Prof.         
Sponsors and Collaborators
St. Josef Hospital Bochum
  More Information

Publications:
Responsible Party: Woitalla, Dirk MD, Neurologische Universitätsklinik der Ruhr-Universität Bochum
ClinicalTrials.gov Identifier: NCT01385735     History of Changes
Other Study ID Numbers: 2011-TevAzi
Study First Received: June 28, 2011
Last Updated: June 29, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by St. Josef Hospital Bochum:
Parkinson Disease
Emotion
mood
executive function

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014